Lenire — Bimodal Stimulation Treatment by Neuromod

[threefirefour]

That goes without saying.

But even among the users that were already on here we should be seeing a similar trend. If you look at the user reviews, it's a closed system with neither positive nor negative comments coming from outsiders. Just about everyone who has undergone treatment was on this forum before. We should still see similar numbers once we get a large enough user group.

Well there was one outside user who was using Lenire who made an account just to say he had a worsening.

 

[Ruse]

Well there was one outside user who was using Lenire who made an account just to say he had a worsening.

I count Gee82 from today (no improvement overall and possible worsening) and Ade (worsening).

 

[threefirefour]

I count Gee82 from today (no improvement overall and possible worsening) and Ade (worsening).

For my three were Allan1967, Gee82, and Ade (the outside person).

 

[Bartoli]

Well there was one outside user who was using Lenire who made an account just to say he had a worsening.

I stand corrected then. Btw: thanks for digging out the data and making your graph on the current state of the results.

 

[Bartoli]

The Sonic Labs device targets the inferior colliculus.

I had to look that up. They believe that stress and attention levels can influence the effectiveness of their neuromodulation treatment. Interesting as this has been pondered here before.

Do you know if and when they plan to commercialize?

 

[Ruse]

For my three were Allan1967, Gee82, and Ade (the outside person).

Apologies, I mean Gee82 (first post today) and Ade were the outside people!

 

[Shelly75]

I have been talking to someone who took part in the trial, and had a good improvement, only to have their tinnitus come back again. He's been using the device now for the 2nd time and has gone down from a 7/10 to a 5/10. I don't want to name him as I haven't checked with him first.

 

[Ruse]

I have been talking to someone who took part in the trial, and had a good improvement, only to have their tinnitus come back again. He's been using the device now for the 2nd time and has gone down from a 7/10 to a 5/10. I don't want to name him as I haven't checked with him first.

Thanks for the info! Much appreciated.

Do you know what arm of the trial he was on?

Important to note that Neuromod did find that some timings / setting did not induce permanent effects.

 

[threefirefour]

I had to look that up. They believe that stress and attention levels can influence the effectiveness of their neuromodulation treatment. Interesting as this has been pondered here before.

Do you know if and when they plan to commercialize?

I was looking through med research, and saw they plan to end their second trial before 2027. That being said, it also said Susan Shore plans on ending her second trial in 2024 and it's clearly going to happen much sooner, probably in 2020. Once they finish this second trial they can aim for FDA clearance.

 

[Shelly75]

Thanks for the info! Much appreciated.

Do you know what arm of the trial he was on?

Important to note that Neuromod did find that some timings / setting did not induce permanent effects.

He is one of the people featured in the testimonial videos so I can vouch they are genuine users and not paid actors.

 

[RJames]

First time poster and only signed up to share this story as I think it could be of benefit to some.

I'm an Irishman living in London who has been following Neuromod for almost 2 years now since having found out a family friend was in the 'TENT-A1' study.

My Ma mentioned she knew someone who had been on a treatment programme following the onset of my tinnitus in late 2017.

I was initially very blasé about it as both my GP and ENT had told me that there was categorically no treatment available aside from CBT. Curiosity / desperation got the better of me and I eventually got in touch.

She told me was that there was a volume reduction that knocked her tinnitus down so that she 'no longer heard it above the TV'. She had tinnitus for around 5-6 years though never knew the reason why it came about.

She was very adamant that there was a good improvement from the treatment and even sent me a text earlier this year letting me know the device was released back in Ireland.

This account of her experience and some of the trial data advertised was enough for me to decide to make the plunge and put my name down on the waiting list.

Hope this is useful.

I don't usually post on forums though may consider leaving a review when I eventually get my appointment!

Just a quick update for you all. I spoke to my ma's friend again. I didn't mention on my post above that she had decided to try the paid 12 week treatment to see if she could get a further reduction.

Following the paid treatment she did have a further reduction in volume (although not as much as in the trial) and now her tinnitus does not really bother her much at all.

She says that Neuromod told her they have been able to help the majority of people but not all.

On a side note has anyone been booked in for 2020 appointments yet?

 

[GlennS]

It's just weird that the most positive stories aren't Tinnitus Talk members and we're having to hear them second-hand.

 

[threefirefour]

It's just weird that the most positive stories aren't Tinnitus Talk members and we're having to hear them second-hand.

Actually the number of Tinnitus Talk successes and outer successes roughly balance out right now, with Tinnitus Talk successes in the lead. But you're right it's unusual that so far all outside stories other than Gee's and Ade's are successes.

 

[AfroSnowman]

It's just weird that the most positive stories aren't Tinnitus Talk members and we're having to hear them second-hand.

If we assume these reports are authentic then either we are a self-selected group of more severe cases or we are self-selecting to report when feeling down/disappointed on a bad day.

 

[lcj]

Lenire says they had a clinically significant improvement rate of 66%, and statistically significant improvement rate of 80%. As we add more data we climb closer to the 66% rate. Now why this number isn't reflected on Tinnitus Talk is probably for one of three reasons:

-We got statistically unlucky, and many who don't improve just happen to be Tinnitus Talk users, over representing the unlucky pool.
-Lenire doesn't work as well as Neuromod claims it does.
-There's another reason. Maybe people who use Tinnitus Talk are more likely to have loud invasive tinnitus, meaning they don't experience as much of a reduction as a moderate sufferer would. Also there's a lot of hearing loss on here, and the better your hearing, the more likely Lenire will help you.

I have a question. Were the pre-market trials (MuteButton) conducted using Bluetooth wireless headphones, or a wired device? Was the tongue tip similar in shape and with the same number of electrodes (that may not be the correct term but you get the gist)?

If the device was different mechanically in any minor way that could also be contributing to the differences we are observing between the trial results and the current group of testers.

 

[AfroSnowman]

On a side note has anyone been booked in for 2020 appointments yet?

Two weeks became four, Sept-Oct became end of Oct, end of Oct became we'll schedule you at an indeterminate time in the future.

I'm very interested in whether anyone has heard anything about this as well.

 

[Don Tinny]

It's just weird that the most positive stories aren't Tinnitus Talk members and we're having to hear them second-hand.

Probably this forum is used mostly by severe sufferers. Just a thought.

 

[friend74]

Is it weird? How many Tinnitus Talk members are trying Lenire, or might have tried it? And how many might have written about their experience? Maybe 15 or 20?

How many in general?

 

[Ivkopivko]

Did you pick up a Lenire yet? I read in one of your past posts you planned to.

I'm there tomorrow and hope the flight won't ruin my ears as this is my first flight with tinnitus (I bought Peltor earmuffs for this occasion). Then I'll most probably visit Jameson or Guinness museum and get myself drunk to wash down all the accumulated stress connected with this trip.

I have mixed feelings as I feel kind of down based on latest user experiences, but at the same time I'm looking forward to this trip to explore Dublin as we're going to stay there with my girlfriend until Sunday evening and found very nice AirBnb spot to stay in.

 

[GlennS]

Probably this forum is used mostly by severe sufferers. Just a thought.

Sure, if you subscribe to the theory that severe sufferers are the least amenable to treatment.

 

[GlennS]

Is it weird? How many Tinnitus Talk members are trying Lenire, or might have tried it? And how many might have written about their experience? Maybe 15 or 20?

How many in general?

I don't think the total number of patients with Lenire is that big in the first place, considering that the office isn't even open all week long and part of the office time is designated for follow-ups.

 

[AliceW]

I'm there tomorrow and hope the flight won't ruin my ears as this is my first flight with tinnitus (I bought Peltor earmuffs for this occasion). Then I'll most probably visit Jameson or Guinness museum and get myself drunk to wash down all the accumulated stress connected with this trip.

I have mixed feelings as I feel kind of down based on latest user experiences, but at the same time I'm looking forward to this trip to explore Dublin as we're going to stay there with my girlfriend until Sunday evening and found very nice AirBnb spot to stay in.

If you are sensitive, use earplugs made for plane flights to equalize pressure.

I was anxious too because I've always been sensitive during flights and since my acoustic shock I hadn't flown on a plane... I wore the special earplugs and the flight was still very painful for my left ear, especially the descent... these small planes are poorly pressurized. My husband even suffered barotrauma (level 2) on the flight during the descent.

No luck with our ears... So you'd better wear earplugs to help with the pressure.

 

[JayBowson]

Sure, if you subscribe to the theory that severe sufferers are the least amenable to treatment.

It's not a theory. It's in the numbers.

A 15-20 THI improvement is going to feel like a lot to someone in the 30-50 THI range.
A 15-20 THI improvement is going to feel like relatively little improvement to someone with a THI above 100.

We've known for a while now that Lenire doesn't scale with how severe you are but floats in a roughly average static range of improvement across the board (assuming that the results from the trial translate into the real world of course). So this shouldn't be coming as a surprise really.

 

[ajc]

We've known for a while now that Lenire doesn't scale with how severe you are but floats in a roughly average static range of improvement across the board

This makes me think most of the "benefit" (if you get any) is from the placebo effect since the effect is similar across the board.

Also, THI max is 100, so your "above 100" is not possible...

 

[JayBowson]

This makes me think most of the "benefit" (if you get any) is from the placebo effect since the effect is similar across the board.

This question is dealt with in the recent Q&A. The community defines the difference between placebo and effective treatment. Neuromod are only going by these guidelines.

Also, THI max is 100, so your "above 100" is not possible...

True. I got that detail wrong, I mistakenly thought it was 150. The point I was making still holds though, my mistake not withstanding.

 

[Ivkopivko]

It's not a theory. It's in the numbers.

A 15-20 THI improvement is going to feel like a lot to someone in the 30-50 THI range.
A 15-20 THI improvement is going to feel like relatively little improvement to someone with a THI above 100.

We've known for a while now that Lenire doesn't scale with how severe you are but floats in a roughly average static range of improvement across the board (assuming that the results from the trial translate into the real world of course). So this shouldn't be coming as a surprise really.

It looks like it follows the pattern you mentioned, however a few lucky people experienced even more improvement.

I was hoping that this was going to be the case if the duration of the treatment was extended to over 12 weeks, or with more stimulation changes... but we're not that lucky.

 

[El BUZZ]

I'll be in Dublin tomorrow and will leave Saturday morning just in case someone wants to catch up for a pint.

 

[ruud1boy]

For my three were Allan1967, Gee82, and Ade (the outside person).

I can vouch for Ade - he's a regular BTA member and only came on here to post about his experience 'cos I twisted his arm, metaphorically.

 

[GlennS]

A 15-20 THI improvement is going to feel like a lot to someone in the 30-50 THI range.
A 15-20 THI improvement is going to feel like relatively little improvement to someone with a THI above 100.

But it's not about curing tinnitus. It's about being able to sense improvement above and beyond placebo. That should still be possible even for those with severe tinnitus. So I don't buy this. For instance, the tinnitus in my left ear is pretty damn bad compared to my right. If it were to drop down roughly in line with my right, I'd absolutely be able to sense this, even though I'm not exactly thrilled with the tinnitus in my right ear either. I'm not so insensitive to tinnitus levels that I can't accurately judge incremental improvement.

 

[JayBowson]

But it's not about curing tinnitus. It's about being able to sense improvement above and beyond placebo.

You entire point hinges on your definition of placebo. It simply isn't up to you to decide that level fortunately.